Quality Specialist I

Location: Labs HQ, PA

Job Description

Quality Specialist I

Description: Azzur Labs is seeking Quality Specialist of their PA Laboratory. The Quality Specialist I supports the company’s quality assurance and control programs. The Quality Specialist I is responsible for document review and control, inventory control, and quality control of incoming materials. The Quality Specialist I will assist the Quality Director in assuring that the quality management system is implemented and followed.

Job Responsibility:

1. Ensures all incoming materials are tested and found to be of acceptable quality before use.
2. Responsible for assisting in the conduct of internal audits.
3. Assists in conducting investigations of laboratory deviations and client exceeded concern levels.
4. Maintains training records and documentation.
5. Reviews documentation, such as, raw data and reports (Environmental monitoring, water,
media fill, bioburden), logbooks (beginner to intermediate level), quality control records, and quality assurance records for completeness, accuracy and compliance with methods, protocols, guidelines, regulations and Azzur Labs LLC quality systems.
6. Assures proper control of laboratory testing as needed for review.
7. Maintains familiarity with laboratory testing as needed for review.
8. May draft or review client notifications of exceeded levels.
9. Collaborates with the implementation, maintenance and improvement of quality systems.
10. Reads standards, journals and publications to keep abreast with requirements and developments in applicable technologies.

Requirements:

- At least 1 year of experience in a regulated industry, preferably in quality or laboratory operations.
- Related or equivalent experience by be substituted.

Preferred Experience:

- 1 years’ experience in quality role.
- Previous experience in batch record or documentation review.
- Desired background in Microbiology
- American Society for Quality Certified Quality Technician or other certification.

Skills (including typical mental demands):

Reasoning Ability/Mathematical Skills/Computer Skills/Language Skills:
- Computer skills
- Mathematical skills

Required Education:

- High School Diploma or Equivalent

Preferred Education:

- Bachelor of Science or Bachelor of Arts in a science field

Benefits:

- Flexible PTO
- Training and Development Opportunities
- 401(k) match
- Medical Benefits
- Paid Holidays

At Azzur, we understand how to help companies in the health and life science industry bring their projects to life, and follow them from Discovery to Delivery™. We believe success is carefully calibrated, precisely executed, and thoroughly monitored. Our nationwide network of companies is dedicated to providing continuous service to customers in the pharmaceutical, biotechnology, medical device, diagnostics, biologics and clinical industry, as well as all HLS suppliers. We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers. Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values: Put Others First, Have the Courage to Take Action, Take Personal Responsibility and Have Fun!

Azzur Group is an equal opportunity employer and promotes diverse culture, ethnicity, gender and age in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate.


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